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FDA 510(k)

ACUFEX COMPARATIVE SURGICAL KERATOMETER

K-Number: K852424 · 1985-09-11

ApplicantAcufex Microsurgical, Inc.
Decision Date1985-09-11
Product CodeHJB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ACUFEX COMPARATIVE SURGICAL KERATOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Acufex Microsurgical, Inc.. It received FDA 510(k) clearance on 1985-09-11 under 510(k) number K852424. The device is classified under product code HJB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUFEX COMPARATIVE SURGICAL KERATOMETER?

ACUFEX COMPARATIVE SURGICAL KERATOMETER is a medical device that received FDA 510(k) clearance on 1985-09-11. The listed applicant is Acufex Microsurgical, Inc.. The 510(k) number is K852424.

When did ACUFEX COMPARATIVE SURGICAL KERATOMETER receive FDA 510(k) clearance?

ACUFEX COMPARATIVE SURGICAL KERATOMETER received FDA 510(k) clearance on 1985-09-11, under 510(k) number K852424.

Who is the listed applicant for ACUFEX COMPARATIVE SURGICAL KERATOMETER?

The FDA 510(k) record lists Acufex Microsurgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACUFEX COMPARATIVE SURGICAL KERATOMETER?

The FDA product code for ACUFEX COMPARATIVE SURGICAL KERATOMETER is HJB.

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Other records listing Acufex Microsurgical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K961555ACUFEX TAG BIOABSORBABLE ANCHORSK961853PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSERK954246ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREWK952535ACUFEX ENDOBUTTON TAPEK953276ACUFEX TAG DELIVERY SYSTEMK953459ACUFEX TAG ANCHOR

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Related Devices (Code: HJB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K930444MARCO STANDARD KERATOMETERSMarco Ophthalmic, Inc.K924779BURTON KERATOMETER - MODLE 2040R.H. Burton Co.K864369LTS CORNEAL MICROSCOPE LASER TOMOGRAPHIC SCANNERHeidelberg InstrumentsK864037KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZERKera Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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